This invention relates to improved breast prostheses suitable for implantation in a human breast for reconstructive or cosmetic purposes.
Surgical reconstruction of human breasts as a result of injury or as a result of partial or total mastectomy has been performed for many years. Various surgical prostheses have been developed for implantation in the human breast as a part of breast reconstruction or augmentation. See for example my U.S. Pat. No. 3,293,663. The ability of a physician to offer a patient who has undergone a mastectomy a lifelike substitute for the breast which has been removed is an important element in the rehabilitation of the patient.
A major problem with prostheses heretofore used is the lack of maintained projection, particularly in a manner such that the proper shape and location on the chest wall would be achieved and maintained, and the fact that their shape and consistency generally does not match the remaining breast. In an effort to overcome said problems a number of types of implants have been proposed. See for example, U.S. Pat. No. 4,650,487 to Chaglassian in which a high projection implant was proposed by utilizing two shells or lumens in which the inner lumen is secured to the rear wall of the outer lumen and in which the material contained in the inner lumen is of a higher density than that contained in the outer lumen. There is no disclosure in said patent, however, of a construction in which the inner lumen is unattached and free to move within the outer lumen so as to provide a prosthesis which closely simulates the natural flow of breast tissue during daily activities.
Another proposed solution to this problem is disclosed in U.S. Pat. No. 4,636,213 in which a prosthesis is proposed which is provided with valves so that additional fluid can be introduced into the prosthesis by means of an injection needle. This patent likewise does not teach the use of a prosthesis in which an unattached inner lumen is provided. If implants utilizing an attached inner lumen for maintaining projection are not positioned correctly during surgery the projection which is provided is not in an optimum position on the patient.
Canadian Pat. No. 1,059,262 discloses an external breast prosthesis. Such external prostheses are simply attached over the chest area of the patient and may be removed at night if desired. The prosthesis shown in said patent includes a silicone or other filler such as glycerin in which a bag of air is inserted to reduce its weight. There is no disclosure, in said patent, however, of an unattached fluid filled envelope designed to simulate the natural flow of tissue within a human breast.
A silicone gel-saline implant utilizing an inner, silicone gel filled lumen which is unattached within an outer lumen which is filled by the surgeon with a saline solution has been marketed by Dow Corning Wright Corporation of Arlington, Tn. See their sales literature identified as Form No. L080-0101. Such commercially available implants have, however, heretofore always employed an inner lumen which was of the same shape (generally a flattened cushion or dome shape having a flattened rear side) having a height and diameter nearly as great as that of the outer lumen. The inner lumen in such constructions was therefore not motile except to a very limited degree, and did not serve to provide or maintain the projection of the implant.